Largos Supervivientes, Tenemos datos?
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1 Largos Supervivientes, Tenemos datos? Javier Puente, MD, PhD Medical Oncology Department. Hospital Clinico San Carlos Associate Professor of Medicine. Complutense University of Madrid.
2 Summary
3 Snapshot Cancer Care 20 years ago
4 Cancer Genomics Advent of the precision medicine era But cancer s biology is far more complex than we had imagined Schilsky R. ASCO 2016
5 Rise of Immunotherapy Game-changing discoveries-more coming Schilsky R. ASCO 2016
6 Since the 1990s: Mortality down, Survivorship Up In the United States DeSantis C, et al. CA A Cancer Journal for Clinicians 2014
7 Long-survivals Take into account LONG SURVIVAL? Enough Follow-up Perspective
8 Long-survivals 4 examples with Immunotherapy 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Renal cancer 4. Melanoma
9 Long-survivals 4 examples with Immunotherapy 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Renal cancer 4. Melanoma
10 NSCLC Lung Cancer Outcome: 8th TNM Estadio IV 38% Estadio III 31% Estadio II 7% Estadio I 24%
11 NSCLC Lung Cancer Outcome: first data KeyNote-001 : 3 yrs OS CA Study: 3 yrs OS 3y OS- 19% 3y OS- 18% 3y OS- 29% in PDL1 >50% Gettinger et al. JCO 2014; Leighl ASCO 2017
12 NSCLC Lung Cancer Outcome: first data CA Study: 5 yrs OS Brahmer, et al. AACR-2017
13 NSCLC Lung Cancer Outcome: first data CA Study: 5 yrs OS Brahmer, et al. AACR-2017
14 NSCLC Lung Cancer Outcome: first data CA Study: 5 yrs OS Brahmer, et al. AACR-2017
15 NSCLC Classic results with chemo Reck et al Lancet Oncol 2014; Garon et al. Lancet Oncol 2014
16 NSCLC Immunotherapy in pretreated patients Borghaei H, et al. ASCO 2016; Brahmer et al. AACR 2017; Herbst RS, et al. ASCO 2017; Rittmeyer A, et al. Lancet 2017
17 OS (%) OS (%) NSCLC Nivolumab 2L: 3 year survival rate CheckMate 017 (SQ NSCLC) CheckMate 057 (non-sq NSCLC) Nivolumab (n = 135) Docetaxel (n = 137) HR (95% CI): 0.62 (0.48, 0.80) Nivolumab (n = 292) Docetaxel (n = 290) HR (95% CI): 0.73 (0.62, 0.88) No. of patients at risk 1-y OS = 42% Δ18% 2-y OS = 23% 20 1-y OS = 24% 3-y OS = 16% 20 Δ15% Δ10% 2-y OS = 8% 3-y OS = 6% Months 1-y OS = 39% Months No. of patients at risk 1-y OS = 51% 2-y OS = 16% 2-y OS = 29% Δ9% 3-y OS = 9% 3-y OS = 18% Nivolumab Nivolumab Docetaxel Docetaxel Δ12% Δ13% CI = confidence interval; HR = hazard ratio Borghaei H, et al. ASCO 2016; Brahmer et al. AACR 2017; Herbst RS, et al. ASCO 2017; Rittmeyer A, et al. Lancet 2017
18 NSCLC Nivolumab 2L: 3 year survival rate Felip E, et al. ESMO 2017
19 NSCLC Nivolumab 2L: 3 year survival rate Felip E, et al. ESMO 2017
20 NSCLC Nivolumab 2L: 3 year survival rate and by PD-L1 expression Felip E, et al. ESMO 2017
21 NSCLC Pembrolizumab 2L Keynote 010: 30-months OS (all population) Herbst at al. ASCO 2017
22 NSCLC Atezolizumab 2L OAK: OS ITT population at 2 years Satouchi et al. WLCC 2017
23 NSCLC Long survivors 1st line phase I 8 th TNM IASLC Classification, 3-y OS M1c: ~8% Eberhardt et al. JTO 2015; Leighl et al. ASCO 2017
24 NSCLC Long survivors 1st line phase I Keynote 024, Pembrolizumab in PD-L1 positive patients Reck, et al. NEJM 2016
25 NSCLC Long survivors 1st line phase I Keynote 024, Pembrolizumab in PD-L1 positive patients 2 ys OS 51.5% vs 34.5% HR % Crossover Reck, et al. NEJM 2016
26 NSCLC Long survivors 1st line phase I CheckMate 012: Nivolumab plus ipilimumab WLCC 2017
27 NSCLC Long survivors 1st line Keynote-021 Borghaei, et al. WLCC 2017
28 ORR, % (95% CI) NSCLC Long survivors 1st line Keynote Δ24.8% (95% CI, 7.2% 40.9%) P = a 57% 37% 52% 29% Median (95% CI) 19.0 (8.5 NR) 8.9 ( ) 0 Pembrolizumab + PC PC Alone Events, n/n HR (95% CI) Pembro + PC 26/ PC alone 40/63 ( ) P = a Borghaei, et al. WLCC 2017
29 NSCLC Long survivors 1st line Keynote % 69% 70% 56% Median (95% CI) NR (22.8 NR) 20.9 (14.9 NR) Crossover ~ 75% Borghaei, et al. WLCC 2017
30 Long-survivals 4 examples with Immunotherapy 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Renal cancer 4. Melanoma
31 Urothelial carcinoma Percent of cases & 5-year relative survival Slide from E. Grande. Best of GU 2015
32 Snapshot Cancer Care 20 years ago
33 Urothelial carcinoma Overall survival Fit for Cisplatin Cisplatin ineligible (unfit) Median OS 8.1m 9.3m von der Maase, et al. J Clin Oncol 2005 De Santis, et al. J Clin Oncol 2012 Galsky, et al. Lancet Oncol 2011
34 Urothelial carcinoma Overall survival Role of taxanes in the 2nd line Pal S, et al. Plos One 2015
35 Urothelial carcinoma Overall survival Role of vinflunine in the 2nd line Bellmunt J, et al. J Clin Oncol 2009
36 Urothelial carcinoma Long survivors 2nd line Keynote-045: pembrolizumab as second-line Patients with metastatic or locally advanced UC after recurrence or progression following platinum-based chemotherapy; ECOG PS 2; evaluable tumor tissue for PD-L1 testing (N = 542) Pembrolizumab 200 mg Q3W (N = 270) Investigator s Choice Paclitaxel 175 mg/m 2 Q3W or Docetaxel 75 mg/m 2 Q3W or Vinflunine 320 mg/m 2 Q3W (N = 272) Treated up to 24 mos or until CR, PD, unacceptable AE, or investigator decision* Treated until PD, unacceptable AE, or patient withdrawal of consent Primary endpoints: OS, PFS in overall and in PD-L1 CPS 10% populations Secondary endpoints: ORR, DoR in overall and in PD-L1 CPS 10% populations; safety Bellmunt J, et al. NEJM 2017
37 Urothelial carcinoma Long survivors 2nd line Bellmunt J, et al. NEJM 2017
38 Urothelial carcinoma Long survivors 2nd line Petrylak, et al. ESMO 2017
39 Urothelial carcinoma Long survivors 2nd line Atezolizumab in muc: IMvigor 210 Response Rate - primary endpoint Rosenberg J, et al. Lancet 2016
40 Urothelial carcinoma Long survivors 2nd line Atezolizumab in muc: IMvigor 210 OS data from Atezolizumab in UBC Rosenberg J, et al. Lancet 2016
41 Urothelial carcinoma Long survivors 1st line Atezolizumab in muc: IMvigor 210 Balar A, et al. Lancet 2017
42 Urothelial carcinoma Long survivors 2nd line Atezolizumab in muc: IMvigor 210 Rosenberg J, et al. Lancet 2016
43 Urothelial carcinoma Long survivors 2nd line Nivolumab: phase II Check-Mate 275
44 Long-survivals 4 examples with Immunotherapy 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Renal cancer 4. Melanoma
45 Proportion surviving Kidney cancer Overall survival Surgical classic data 1.0 MSKCC classic data months Years following systemic therapy Topalian et al. SITC 2017
46 Kidney cancer Overall survival CheckMate 003 Topalian et al. SITC 2017
47 Kidney cancer Overall survival CheckMate 025 Sharma P, et al. KCA 2017
48 Kidney Cancer Overall survival Hammers et al. ESMO 2016
49 Kidney Cancer Overall survival Hammers et al. ESMO 2016
50 Long-survivals 4 examples with Immunotherapy 1. Non-small cell lung cancer 2. Urothelial carcinoma 3. Renal cancer 4. Melanoma
51 Melanoma Overall survival Historical controls Middleton MR, et al JCO 2000
52 Melanoma Overall survival Ipilimumab Pool analysis Schadendorf et al. JCO 2015
53 Melanoma Overall survival Hodi et al. AACR 2016; Robert et al. ASCO 2016
54 Melanoma Overall survival CheckMate 063: Nivolumab vs Dacarbazine
55 Melanoma Overall survival Keynote 006: Pembrolizumab Robert et al. NEJM 2015; Schachter et al. SMR 2015
56 Melanoma Overall survival CheckMate 069/067: Pooled 3-year analysis Postow et al. SITC 2017
57 Long-survivals Expectations
58 Melanoma Overall survival LONG TERM SURVIVAL Schadendorf et al. JCO 2015
59 @docjavip
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